how to prepare for and implement the upcoming mdr – dos and

How to prepare for and implement the upcoming MDR – Dos and don’ts

Gert Bos, Head of Regulatory and Clinical Affairs, BSIErik Vollebregt, Partner at Axon Lawyers

Flags of the member states of the EU

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© BSI BSI/UK/779/ST/0116/EN

IntroductionIn the previously published white paper, The proposed EU regulations for medical and in vitro diagnostic devices: An overview of the likely outcomes and the consequences for the market, a summary was given of the legislative changes likely to be brought about by the new EU Medical Devices Regulation (MDR) and IVD Regulation (IVDR). Both regulations are in the final stages of the legislative procedure and are estimated to finish sometime in 2016, allowing them to come into effect by the end of 2016, or early 2017. Some time would be needed to polish the agreed text and have it translated into the official EU languages.

In contrast to the previous white paper, this white paper will provide information on the impact on manufacturers and is based on the tables featured at the end of the MDI chapters. These tables provide a checklist for MDR preparation, based on our current understanding of MDR. The checklist provides a comprehensive list of actions currently envisaged for the manufacturer before, during and after the transitional period of the MDR, for each chapter of the MDR and its annexes. The IVDR will be discussed in the same way in a separate white paper.

In order to provide context to the checklist, each table is preceded by a short discussion of changes for that respective chapter in the MDR. The full table is listed in the Appendix.

Chapter I – DefinitionsA significant number of the definitions may or will change, resulting in products that are currently not classified as medical devices or accessories under the MDD, now included in the scope of the MDR. Examples are the enlarged scope of the definition of accessories that will include devices that specifically or directly assist another device in its intended purpose, the changed definition of custom-made devices that excludes devices that are mass-produced by means of industrial manufacturing processes, and the inclusion of products based on human cell or tissue derivatives. Also, the MDR will apply to non-medical devices with a risk profile similar to medical devices (such as cosmetic implants, contact lenses and cosmetic laser products), which will be included in a list in Annex XV to the regulation.

The MDR now applies to some non-medical devices, such as contact lenses

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Subject Before coming into force During After

Chapter I Definitions

Check if cosmetic implants or other products are on Annex XV list

Look out for Common Specifications (CS) for Annex XV devices and implement them

Check if devices fall in enlarged scope of ‘accessory’

Obtain CE mark for accessory under new regime


Check if custom device is still custom device under new definition

Obtain CE mark if changed to regular medical device

Products specifically intended for the cleaning, disinfection or sterilization of medical devices and devices for the purpose of control or support of conception will be considered medical devices

Make gap assessment for information required for CE marking of devices concerned

Develop and implement transition strategy for devices concerned into CE marking, generate information needed for CE marking

Obtain CE mark for devices concerned under new regime

Standalone software is no longer classified as active medical device: revisit classification of software currently on the market as medical device and make gap assessment for additional technical file requirements for software classified in higher risk class

Amend technical files for software in accordance with requirements for higher risk class, have software CE marked by notified body if class IIa or higher

Apply classification rules for new software

ANNEX XV LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE

Identify Annex XV candidate devices in company’s portfolio

Watch for CS becoming available for devices concerned

Start building up technical documentation and if necessary quality management system (QMS)

CE mark Annex XV devices using CS

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New to the MDR is the instrument of Common Specifications (CS). These can be adopted by implementing acts where no harmonized standards exist or where relevant harmonized standards are not sufficient. They can be adopted in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annex II, the clinical evaluation and post-market clinical follow-up (PMCF) set out in Annex XIII or the requirements regarding clinical investigation set out in Annex XIV. Also, the new mechanism of CS will be used to provide design requirements for the Annex XV products.

Chapter II – Making available of devices, obligations of economic operators, reprocessing, CE marking, free movementThis chapter contains a number of major changes that will impact on the existing quality system and its resources, such as:

• the obligation to have a person responsible for regulatory compliance available within the organization. While there is no guidance on the subject yet, ‘have available within the organization’ does not seem to indicate that the person concerned must be an employee of the organization, and that a consultant or other external resource would also fulfil this requirement. The Council’s General Approach text of the MDR specifically states that the responsible person may or may not be an employee of the organization.

• a supply chain regime that will necessitate changes to current distribution and other supply chain agreements. Each actor in the supply chain will have its own regulatory responsibility (e.g. a duty to check compliance of the device and a duty to initiate corrective action), a big change from the current situation; and

• the liability of the various operators, including the authorized representatives (ARs).

The MDR will feature a relabelling and repackaging regime similar to the regime for relabelling and repackaging developed in the case law of the European Court of Justice for medicinal products.

A much-discussed item still on the table is a mandatory product liability insurance for both manufacturers and ARs (in the latter case accompanied by product liability being imposed on ARs as well), which is expected to cause many ARs to cease activities. If this requirement is adopted for ARs, many manufacturers may need to change their AR as a result of them ceasing activity.

Another hotly debated item is the reprocessing of single-use devices foreseen in Article 15. Each of the political actors made very different proposals. The Commission proposed that reprocessing would be permitted but that member states may prohibit it locally. The Parliament wanted to make reprocessing the standard of care, imposing a burden of proof on industry to provide justification if and why specific devices cannot be reprocessed. Finally, the Council aligned with the Commission but wanted an exception for reprocessing in healthcare institutions. Given the wide gap between the respective sides of the debate, it is very difficult to predict at this stage what the final provision in the MDR will look like.


Chapter II Making available of devices, obligations of economic operators, reprocessing, CE marking, free movement

Assess potential effect of reprocessing and home brews under new hospital produced (so called ‘home-brew’) devices rules on company business model

Monitor compliance of hospitals with reprocessing and home brews under new hospital produced devices rules

Monitor compliance of hospitals with reprocessing and home brews under new hospital produced brew devices rules (task of national authorities)

Continued

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Manufacturers must establish, execute, maintain and document a system for risk management as described in Section 1a in Annex I

Manufacturers must conduct a clinical evaluation in accordance with the requirements set out in Article 49 and Annex XIII, including PMCF

Article 5: assess medical devices provided as service via internet

CE mark device as service under new regime

Assess own brand labelling consequences of the requirements that a full technical file must be present at each manufacturer (Article 8 (4))

Change business and certification setup into virtual contract manufacturing, or get all required contracts to access key documentation from original equipment manufacturer (OEM) in place

Review new manufacturer responsibilities and make gap assessment against QMS

Amend and implement amended QMS

Apply QMS optionally to devices placed on the market in transitional period

Apply amended QMS

Make gap assessment against new recall requirements (Article 8 (8))

Amend procedures and distribution agreements – adopt new requirement ‘[8a. Manufacturers shall have a system for reporting of incidents and field safety corrective actions as described in Article 61]’

Make gap assessment against new QMS criteria in Article 8 (5); amend procedures

Implement amended QMS; consider revising directly into new ISO 13485 at the same time

Article 8 (13): mandatory insurance for product liability, monitor developments

Purchase and maintain relevant insurance

Maintain relevant insurance

Continued

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New AR requirements Articles 9–10 – amend AR agreement and procedures – expect AR renegotiations or AR to cease activity if liability requirements are adopted

Ensure continued access to AR services when relevant

Review autonomous general obligations of importers and distributors (Articles 11–12), e.g. verify compliance of the device, inform competent authority of non-compliance of the device and implement corrective action and amend contracts accordingly

Implement standard operating procedures (SOPs), amend agreements in supply chain

Article 13: select and mandate candidate for person responsible for regulatory compliance

Make and keep available in the organization a person responsible for regulatory compliance; ensure training and where appropriate take out personal liability insurance

Keep available in the organization a person responsible for regulatory compliance

Prepare for new relabelling/ repackaging regime (Article 14), draft SOP for new regime

Implement and apply SOP Apply SOP

Article 15: new regime for reprocessing – design traceability that can show if an incoming complaint is about a new or reprocessed single-use device.

Determine what member states will allow reprocessing

Implement traceability that can show if an incoming complaint is about a new or reprocessed single-use device

Ensure any reprocessing results in patient safety to stay on level of first time use

Ensure any reprocessing results in patient safety to stay on level of first time use

Continue to monitor changed allowance per country

Implant card (Article 16 and implementing acts)

Define system of implant cards, or alternative allowed systems

Declaration of conformity (DoC) model (Article 17, Annex III) – check for gaps against current model used

Amend existing DoCs upon transfer per product (group) into the new requirements aligned with transfer plan agreed with notified body

Use MDR provided model of DoC

Article 21: parts manufacturers to ensure that the part does not adversely affect the safety and performance of the device

Parts manufacturers must generate supporting evidence for this

Supporting evidence should be made available to the competent authorities of the member states

Parts manufacturers to generate supporting evidence for each new part placed on the market and to be kept available to the competent authorities of the member states

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Chapter III – Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European databank on medical devices

The EU will rely heavily on the new version of the European databank on medical devices (EUDAMED) currently under construction for traceability, registration of devices and publication of information concerning medical devices on the EU market. The database will be accessible to manufacturers and for the first time, healthcare professionals, end users and the general public will have access to certain parts of the information in EUDAMED. Manufacturers will need to prepare for and implement Unique Device Identifiers (UDIs) for all of their devices, although UDI will be implemented in phases based on the risk classes of the products, eventually leading to all devices requiring a UDI.

Manufacturers will need to provide a summary of safety and clinical performance for class III devices and also for implants of lower classification, which will be a major effort. This summary must include among other things the intended purpose of the device, indications and contra-indications, reference to standards and CS, a summary of clinical evaluations and suggested profile and training of users.

Example UDI label © US Food and Drug Administration website, Medical Devices, Unique Device Identification


Chapter III Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European databank on medical devices

UDI (Article 23 (1)): distributors and importers shall co-operate with the manufacturer or authorized representative (AR) to achieve an appropriate level of traceability of devices – implement changes to distribution agreements

Implement changes to distribution agreements and SOPs

Continued

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Article 23 (2): for devices, other than custom-made or investigational devices, economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 8(4):

(a) any economic operator to whom they have supplied a device;

(b) any economic operator who has supplied them with a device;

(c) any health institution or healthcare professional to whom they have supplied a device. – implement and improve traceability

Put traceability systems in place in supply chain, where possible based on UDI

Article 24 (3): assign UDI to device and higher levels of packaging and (24 (4)) place that on the label and higher levels of packaging and (24a–c and (5)) keep UDI administration for reporting and tech file

Choose type of UDI system to be applied, in line with global requirements towards UDI

If possible, manufacturers may (Article 24b) apply new process for registration of devices prior to placing on the market

Article 24b: apply new process for registration of devices prior to placing on the market

When implemented, companies may apply process for registration of manufacturers, and ARs and importers, to obtain a single registration number to identify them for the purposes of UDI and traceability

Article 25a: apply process for registration of manufacturers, ARs and importers, single registration number

Article 26: identify information that must be reflected in summary of safety and performance for each device and conceive plan for generating summaries for each class III and implantable device

Article 26: execute plan for producing summaries for each device

Make available summaries for implantable and class III certified under MDR

Article 26: draw up and make available summary of safety and clinical performance for class III and implantable devices, other than custom-made or investigational devices

Continued

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If available, Article 27: enter data into EUDAMED

Article 27: enter data into EUDAMED

ANNEX V INFORMATION TO BE SUBMITTED WITH THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS

Perform gap analysis of information for EUDAMED database and for UDI purposes

Prepare for implementation for EU-UDI

Implement EU-UDI for existing and new devices and register them in EUDAMED database

Use EU-UDI and register new devices in EUDAMED

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Chapter IV – Notified bodiesNotified body supervision will change considerably and all notified bodies will need to apply for a new designation during the transitional period. It is currently expected that as a result, a significant number of notified bodies (estimated at 50%) may not be re-notified at all or may not be notified for the same scope under the new regulation. Consequently, manufacturers must be aware that they may need to change notified body and act accordingly if their current notified body is not able to support the manufacturer anymore.

The process of re-designation will take up the first part of the transitional period, as the designation criteria are still to be fully defined, and the process of periodic joint assessments by teams of member states and commission services will be resource-heavy.


Chapter IV Notified bodies

Make assessment of notified body’s potential to be re-notified under new system

Re-notification to be timely; with long delays in re-notification, consider alternative plans

Agree re-assessment plan with current notified body or agree transition plan to new notified body if necessary

Article 36: analyse and implement new transition procedures for dealing with consequences of changes in designation and cessation of notified bodies

ANNEX VI MINIMUM REQUIREMENTS TO BE MET BY NOTIFIED BODIES

Contact notified body to discuss if it can meet the new requirements and prepare for transition if needed

Notified body may or may not be re-notified under new criteria; move to new notified body in case notified body not re-notified or has scope restricted as to not support devices concerned any longer

ANNEX XII MINIMUM CONTENT OF CERTIFICATES ISSUED BY A NOTIFIED BODY

No action required by manufacturer



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Chapter V – Classification and conformity assessmentThe classification rules will change for certain devices, which will impact on affected devices currently on the market. These devices may need to be recertified in another – typically higher – risk class. This will impact particularly nanotechnology and substance-based medical devices, specific orthopaedic implants (spinal disk replacements), re-usable surgical instruments and life-saving active medical devices such as an automated external defibrillator (AED).

Changes in the conformity assessment rules will impact existing quality systems and will also require manufacturers to revisit the structure and content of current technical files. For example, the regulation will feature new essential safety and performance requirements (the current Essential Requirements) and a mandatory technical file structure and content. Focus on the review of lower risk devices will be much stronger on clinical evaluation, and for lower risk products.

The classification rules will change for certain devices such as reusable surgical instruments


Chapter V Classification and conformity assessment

Perform a gap analysis of all devices on the market against new classification rules and make transition plan if classification necessitates new conformity assessment, class II implants may be subject to additional clinical scrutiny procedure (Article 42 (2a))

Implement transition plan for reclassified devices

Continued

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Apply new conformity assessment procedures to devices already on market and optionally to new devices to be placed on the market

Select devices which have documentation to support the new essential principles

Apply new conformity assessment procedures to devices

Article 42: make QMS gap analysis against the new rules

Apply new QMS optionally in case of new devices to be placed on the market

Apply new QMS in case of new devices to be placed on the market

Article 46: conclude tripartite transition agreement with outgoing and incoming notified body in case of voluntary change of notified body

Do gap assessment of consequences of new substance-based devices rule 21 (class IIb default, class IIa in case on skin, class III if systematically absorbed)

Work on reclassification where appropriate

Apply new classification rule 21

Do gap assessment for consequences of spinal implants reclassification (spinal disc replacement implants and implantable devices that come into contact with the spinal column, in which case they are in class III with the exception of components such as screws, wedges, plates and instruments, rule 8)



ANNEX I GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

Gap analysis of consequences of changed ‘essential requirements’ for recertification of existing devices (rule 21, Annex XV, new software requirements)

Gap analysis of requirements for new devices

Gap analysis of consequences of changed ‘essential requirements’ for recertification of existing devices (rule 21, Annex XV)


Continued

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ANNEX II TECHNICAL DOCUMENTATION

Gap analysis of existing technical files against new technical file requirements

Amend existing technical files against new technical file requirements and recertification based on amended technical file

Use new technical file requirements

ANNEX III EU DECLARATION OF CONFORMITY

Gap analysis of existing DOC against new DOC requirements

Amend existing DOC against new DOC requirements and recertification based on amended technical file

Use new DOC requirements

ANNEX IV CE MARKING OF CONFORMITY

No changes No changes No changes

ANNEX VII CLASSIFICATION CRITERIA

Analyse devices under new classification criteria to determine if they will be reclassified

Recertification of existing devices under new classification rules

Apply new classification rules to new devices

ANNEX VIII CONFORMITY ASSESSMENT BASED ON FULL A QUALITY MANAGEMENT SYSTEM ASSURANCE AND DESIGN EXAMINATION

Perform gap analysis between current full QMS and new full QMS requirements, improve QMS where necessary

Recertification of existing devices under new QMS

Apply new QMS

ANNEX IX CONFORMITY ASSESSEMENT BASED ON TYPE EXAMINATION

Perform gap analysis between current type examination QMS and new type examination QMS requirements, improve QMS where necessary


Apply new QMS

ANNEX X CONFORMITY ASSESSEMENT BASED ON PRODUCT CONFORMITY VERIFICATION

Perform gap analysis between current product verification QMS and new product verification QMS requirements, improve QMS where necessary


Apply new QMS

ANNEX XI CONFORMITY ASSESSMENT PROCEDURE FOR CUSTOM-MADE DEVICES

Apply procedure for custom-made devices optionally to devices in scope

Apply procedure for custom-made devices in scope

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Chapter VI – Clinical evaluation and clinical investigationsThe MDR will put in place a European regimen for clinical investigations that will replace the diversity of member state regulation in the EU. It will introduce many new concepts relating to clinical evaluation and clinical investigation, as well as a mandatory PMCF and periodic safety update reports (also known as PSURs). This will require a thorough review of the manufacturer’s clinical strategy and PMCF plans. Compliance with the current MEDDEVs on clinical requirements is unlikely to be sufficient for compliance under the new rules. Manufacturers will need to revise not only their clinical strategy for new devices but also perform a gap analysis to identify gaps in clinical evidence under the new rules for devices currently on the market, because the clinical evidence for existing devices needs to be updated. For high-risk devices and permanent implants, a summary of clinical evaluation will be publicly available, so convincing clear evidence will need to be provided in layperson’s terms.


Chapter VI Clinical evaluation and clinical investigations

Understand new clinical requirements (e.g. new definition of ‘clinical data’); define gap between current clinical evaluation of devices and future model according to Article 49

Review and update internal procedures for planning and commissioning clinical investigations

Consider prior review of clinical studies for class III and implantable devices; perform clinical evaluation in accordance with new mode

Check transition timescales and requirements for when this needs to be undertaken to meet the requirements of the new certificate

Continued

Clinical evidence for existing devices will need to be updated

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Define devices that are clinically significantly similar in clinical performance and safety on the market and make gap assessment for substantiating equivalency to amend clinical evaluation for each device currently on the market (Article 49)

Implement plan for amending technical file changes and certification of changes by notified body

Ensure access to equivalency relevant data of other manufacturers by entering into agreement with other manufacturer (Article 49)

Plan to commission own clinical trials if equivalence data will not be acceptable in future

In case of a clinical evaluation relying on equivalency data, the manufacturer doing so must enter into an agreement with the manufacturer of the device referred to, allowing the notified body full access to the technical documentation on an on-going basis (Article 49)

Understand new clinical investigation regime (Articles 50–60)

Prepare for any scrutiny reviews and for scientific pre-meetings with European expert committee

Understand and implement new application and modification mechanism for clinical investigations as well as recording/reporting requirements

Use new application and modification mechanism for clinical trials as well as recording/reporting requirements

Prepare for mandatory PMCF Implement procedures for PMCF

ANNEX XIII CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP

Perform gap analysis of current clinical evaluation method and outcomes per devices against new requirements

Implement new requirements for clinical evaluation

Generate clinical evidence to meet new requirements

Apply new requirements optionally

Generate clinical evidence to new requirements; apply new requirements

Perform gap analysis of current PMCF method and outcomes per device against new requirements

Implement new requirements for PMCF, generate clinical evidence to meet new requirements


Generate PMCF to new requirements; apply new requirements

ANNEX XIV CLINICAL INVESTIGATIONS

Perform gap analysis to determine new clinical investigation requirements and impact on existing clinical investigation plans

Apply new clinical investigation criteria


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Chapter VII – Post-market surveillance, vigilance and market surveillancePost-market surveillance (PMS) and vigilance requirements will be revisited. Manufacturers will need to amend their current PMS and vigilance procedures. PMS will need to be brought into a continuous evaluation and improvement loop, linking to continuous reviews of risk management and to an annual update of a public summary of safety and performance, as well as clinical evaluation.

Manufacturers will need to amend their current post-market surveillance and vigilance procedures


Chapter VII Post-market surveillance, vigilance and market surveillance

Understand new PMS system required and perform gap analysis against current system used

Design and implement new PMS plan (plan for consequences of ongoing PMCF and PMS obligations as long as devices are still in installed base)

Gather PMS clinical data as early as possible on any product currently based on equivalence

Use new PMS system (deal with consequences of ongoing PMCF and PMS obligations as long as devices are still in installed base)

Prepare periodic safety update to notified body reporting according to prescribed model

Understand new vigilance reporting requirements, including new trend reporting requirements

Implement new vigilance reporting requirements

Implement trend reporting system (Article 61a)

Apply new vigilance reporting requirements

Apply new trend reporting requirements

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Chapter IX – Confidentiality, data protection, funding, penaltiesThe regulation makes provision for a penalties regime as well as for possibilities for member states to institute market-funded market surveillance based on the regulation. Companies will need to prepare for additional local costs of market surveillance, as well as for member states changing enforcement policies to align with the regulation.

Chapter VIII – Cooperation between member states, Medical Device Coordination Group, EU reference laboratories, expert panels and device registersThe new regulation will put in place improved and more centralized governance structures, which means that the member states will cooperate closer in cross-border matters on borderline devices and enforcement. On top of that, groups of experts will write a growing number of guidance documents and minimum requirements. These guidance documents will take the form of CS, and will focus heavily on expectations for clinical data sets and minimum patient outcomes for specific categories of devices. The first of such documents – on trans-catheter heart valves TAVI – is currently being worked on and will set the scene.


Chapter VIII Cooperation between member states, Medical Device Coordination Group, EU reference laboratories, expert panels and device registers

Investigate early which scientific discussions might help smooth market introduction at a later stage


Chapter IX Confidentiality, data protection, funding, penalties

Prepare for new penalties regime under MDR

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ConclusionIn conclusion, the MDR will bring about very significant changes that will affect all devices from manufacturers currently on the European market. Not only will the administrative burden increase substantially as a result of registration requirements and UDI, but manufacturers will also have to revisit all technical files and the quality system for all their devices currently on the market. They may need to generate additional clinical evidence for devices currently on the market in order to be able to transition them to the new regime implemented by the MDR.

Consequently, manufacturers must take a pro-active approach to the new regulation, plan for the transition of existing devices in a timely and detailed way, and allocate resources for this effort. Since their notified body may not be around anymore to re-certify devices on the market or new devices, manufacturers must plan for a possible transition from their current notified body.

For the new devices manufacturers must decide whether they want to comply with the new rules already during the transitional period or when that period expires. Again, a pro-active approach is needed as the MDR will require more clinical evidence, especially for higher risk devices, which will take time to generate.

Chapter X – Final provisionsThe transitional regime for the MDR is currently still not fixed. Consequently, manufacturers cannot be sure yet what the transitional regime will look like in terms of (1) transitional period duration and (2) when CE certificates issued under the current Directives will expire. There appears to be political momentum in the Council and Commission camps to extend the transitional period by allowing certificates to be issued under the current rules at the end of the transitional period (three years) for a longer duration (four years), but it is not certain if this will be accepted by the European Parliament.

The Regulation will permit ‘sunshine compliance’, i.e. the possibility to comply with the new rules during the transitional period. Manufacturers will need to carefully review the new rules for each device group and define a strategy to comply with the new requirements. There are many factors to consider, such as when the first notified bodies will be informed under the new rules (likely in the second half of the first year of the transitional period) and the availability of notified body resources to assess and certify the devices concerned.

Under all circumstances, manufacturers will need to invest resources in developing a transition plan for their devices currently on the market, since all such medical devices will need to be (re)certified under the new rules, as no grandfathering has been foreseen in the new EU regulations. This means that none of the devices on the European market will be able to continue under the current rules and all devices must be transitioned into the new system; in most cases technical files will need to be revisited, additional clinical evidence must be generated and declarations of conformity must be amended.


Chapter X Final provisions

Understand transitional regime for devices placed on the market during transitional period

Apply transitional regime for devices placed on the market during 3-year transitional period

Determine and add to transition plan which products might be outfaced and that consequently could stay for a further period on an MDD or Active Implantable Medical Devices (AIMD) certificate after the transition period

Recertify devices on certificates issued during the transitional period under the old rules (up to 2–5 years after end of transitional period)

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Appendix A

Checklist of manufacturer actions before, during and after transitional period


Chapter I Definitions

Check if cosmetic implants or other products are on Annex XV list

Look out for Common Specifications (CS) for Annex XV devices and implement them

Check if devices fall in enlarged scope of ‘accessory’



Check if custom device is still custom device under new definition

Obtain CE mark if changed to regular medical device

Products specifically intended for the cleaning, disinfection or sterilization of medical devices and devices for the purpose of control or support of conception will be considered medical devices

Make gap assessment for information required for CE marking of devices concerned

Develop and implement transition strategy for devices concerned into CE marking, generate information needed for CE marking

Obtain CE mark for devices concerned under new regime

Standalone software is no longer classified as active medical device: revisit classification of software currently on the market as medical device and make gap assessment for additional technical file requirements for software classified in higher risk class

Amend technical files for software in accordance with requirements for higher risk class, have software CE marked by notified body if class IIa or higher

Apply classification rules for new software

Chapter II Making available of devices, obligations of economic operators, reprocessing, CE marking, free movement

Assess potential effect of reprocessing and home brews under new hospital produced (so called ‘home brew’) devices rules on company business model

Monitor compliance of hospitals with reprocessing and home brews under new hospital produced devices rules

Monitor compliance of hospitals with reprocessing and home brews under new hospital produced brew devices rules (task of national authorities)

Manufacturers must establish, execute, maintain and document a system for risk management as described in Section 1a in Annex I

Continued

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Article 5: assess medical devices provided as service via internet

CE mark device as service under new regime

Assess own brand labelling consequences of the requirements that a full technical file must be present at each manufacturer (Article 8 (4))

Change business and certification setup into virtual contract manufacturing, or get all required contracts to access key documentation from OEM in place

Review new manufacturer responsibilities and make gap assessment against QMS

Amend and implement amended QMS

Apply QMS optionally to devices placed on the market in transitional period

Apply amended QMS

Make gap assessment against new recall requirements (Article 8 (8))

Amend procedures and distribution agreements – adopt new requirement ‘[8a. Manufacturers shall have a system for reporting of incidents and field safety corrective actions as described in Article 61]’

Make gap assessment against new QMS criteria in Article 8 (5); amend procedures

Implement amended QMS; consider revising directly into new ISO 13485 at the same time

Article 8 (13): mandatory insurance for product liability, monitor developments

Purchase and maintain relevant insurance

Maintain relevant insurance

New AR requirements Articles 9–10 – amend AR agreement and procedures – expect AR renegotiations or AR to cease activity if liability requirements are adopted

Ensure continued access to AR services when relevant

Review autonomous general obligations of importers and distributors (Articles 11–12), e.g. verify compliance of the device, inform competent authority of non-compliance of the device and implement corrective action and amend contracts accordingly

Implement SOPs, amend agreements in supply chain

Continued

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Article 13: select and mandate candidate for person responsible for regulatory compliance

Make and keep available in the organization, a person responsible for regulatory compliance; ensure training and where appropriate take out personal liability insurance

Keep available in the organization a person responsible for regulatory compliance

Prepare for new relabelling/repackaging regime (Article 14), draft SOP for new regime

Implement and apply SOP Apply SOP

Article 15: new regime for reprocessing – design traceability that can show if an incoming complaint is about a new or reprocessed single-use device

Determine what member states will allow reprocessing

Implement traceability that can show if an incoming complaint is about a new or reprocessed single-use device

Ensure any reprocessing is resulting in patient safety to stay on level of first time use

Ensure any reprocessing is resulting in patient safety to stay on level of first time use

Continue to monitor changed allowance per country

Implant card (Article 16 and implementing acts)

Define system of implant cards, or alternative allowed systems

DoC model (Article 17, Annex III) – check for gaps against current model used

Amend existing DoC upon transfer per product (group) into the new requirements aligned with transfer plan agreed with notified body

Use MDR provided DoC model

Article 21: parts manufacturers to ensure that the part does not adversely affect the safety and performance of the device

Parts manufacturers must generate supporting evidence for this

Supporting evidence shall be kept available to the competent authorities of the member states

Parts manufacturers to generate supporting evidence for each new part placed on the market and to be kept available to the competent authorities of the member states

Chapter III Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, EUDAMED

UDI (Article 23 (1)): distributors and importers shall co-operate with the manufacturer or authorized representative to achieve an appropriate level of traceability of devices – implement changes to distribution agreements

Implement changes to distribution agreements and SOPs

Continued

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Article 23 (2): for devices, other than custom-made or investigational devices, economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 8(4):

(a) any economic operator to whom they have supplied a device;

(b) any economic operator who has supplied them with a device;

(c) any health institution or healthcare professional to whom they have supplied a device – implement and improve traceability

Put traceability systems in place in supply chain, where possible based on UDI

Article 24 (3): assign UDI to device and higher levels of packaging and (24 (4)) place that on the label and higher levels of packaging and (24a–c and (5)) keep UDI administration for reporting and tech file

Choose type of UDI system to be applied, in line with global requirements towards UDI

If possible, manufacturers may (Article 24b) apply new process for registration of devices prior to placing on the market

Article 24b: apply new process for registration of devices prior to placing on the market

When implemented, companies may apply process for registration of manufacturers, and ARs and importers, to obtain a single registration number to identify them for the purposes of UDI and traceability

Article 25a: apply process for registration of manufacturers, authorized representatives and importers, single registration number

Article 26: identify information that must be reflected in summary of safety and performance for each device and conceive plan for generating summaries for each class III and implantable device

Article 26: execute plan for producing summaries for each device

Make available summaries for implantable and class III certified under MDR

Article 26: draw up and make available summary of safety and clinical performance for class III and implantable devices, other than custom-made or investigational devices

If available, Article 27: enter data into EUDAMED

Article 27: enter data into EUDAMED

Continued

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Chapter IV Notified bodies

Make assessment of notified body’s potential to be re-notified under new system

Re-notification to be timely; with long delays in re-notification consider alternative plans

Agree re-assessment plan with current notified body or agree transition plan to new notified body if necessary

Article 36: analyse and implement new transition procedures for dealing with consequences of changes in designation and cessation of notified bodies

Chapter V Classification and conformity assessment

Perform a gap analysis of all devices on the market against new classification rules and make transition plan if classification necessitates new conformity assessment, class II implants may be subject to additional clinical scrutiny procedure (Article 42 (2a))

Implement transition plan for reclassified devices

Apply new conformity assessment procedures to devices already on market and optionally to new devices to be placed on the market

Select devices which have documentation to support the new essential principles

Apply new conformity assessment procedures to devices

Article 42: make QMS gap analysis against the new rules

Apply new QMS optionally in case of new devices to be placed on the market

Apply new QMS in case of new devices to be placed on the market

Article 46: conclude tripartite transition agreement with outgoing and incoming notified body in case of voluntary change of notified body

Do gap assessment for consequences of new substance-based devices, rule 21 (class IIb default, class IIa in case on skin, class III if systematically absorbed)



Continued

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Do gap assessment for consequences of spinal implants, reclassification (spinal disc replacement implants and implantable devices that come into contact with the spinal column, in which case they are in class III with the exception of components such as screws, wedges, plates and instruments, rule 8)



Article 48: uniform certificates of free sale will be issued by member states

Article 48: uniform certificates of free sale will be issued by member states

Chapter VI Clinical evaluation and clinical investigations

Understand new clinical requirements (e.g. new definition of ‘clinical data’); define gap between current clinical evaluation of devices and future model according to Article 49

Review and update internal procedures for planning and commissioning clinical investigations

Consider prior review of clinical studies for class III and implantable devices; perform clinical evaluation in accordance with new mode

Check transition timescales and requirements for when this needs to be undertaken to meet the requirements of the new certificate

Define devices that are clinically significantly similar in clinical performance and safety on the market and make gap assessment for substantiating equivalency to amend clinical evaluation for each device currently on the market (Article 49)

Implement plan for amending technical file changes and certification of changes by notified body

Ensure access to equivalency relevant data of other manufacturers by entering into agreement with other manufacturer (Article 49)

Plan to commission own clinical trials if equivalence data will not be acceptable in future

In case of a clinical evaluation relying on equivalency data, the manufacturer doing so must enter into an agreement with the manufacturer of the device referred to, allowing the notified body full access to the technical documentation on an on-going basis (Article 49)

Understand new clinical investigation regime (Articles 50–60)

Prepare for any scrutiny reviews and for scientific pre-meetings with European expert committee

Understand and implement new application and modification mechanism for clinical investigations as well as recording/reporting requirements

Use new application and modification mechanism for clinical trials as well as recording/reporting requirements

Prepare for mandatory PMCF Implement procedures for PMCF

Continued

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Chapter VII Post-market surveillance, vigilance and market surveillance

Understand new PMS system required and perform gap analysis against current system used

Design and implement new PMS plan (plan for consequences of ongoing PMCF and PMS obligations as long as devices are still in installed base)

Gather PMS clinical data as early as possible on any product currently based on equivalence

Use new PMS system (deal with consequences of ongoing PMCF and PMS obligations as long as devices are still in installed base)

Prepare periodic safety update to notified body reporting according to prescribed model

Understand new vigilance reporting requirements, including new trend reporting requirements

Implement new vigilance reporting requirements

Implement trend reporting system (Article 61a)

Apply new vigilance reporting requirements

Apply new trend reporting requirements

Chapter VIII Cooperation between member states, Medical Device Coordination Group, EU reference laboratories, expert panels and device registers

Investigate which scientific discussions in early phase might help smooth market introduction at a later stage

Chapter IX Confidentiality, data protection, funding, penalties

Prepare for new penalties regime under MDR

Chapter X Final provisions

Understand transitional regime for devices placed on the market during transitional period

Apply transitional regime for devices placed on the market during 3-year transitional period

Determine and add to transition plan which products might be outfaced and that consequently could stay for a further period on an MDD or AIMD certificate after the transition period

Recertify devices on certificates issued during the transitional period under the old rules (up to 2–5 years after end of transitional period)

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MDR Annexes


ANNEX I GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

Gap analysis of consequences of changed ‘essential requirements’ for recertification of existing devices (rule 21, Annex XV, new software requirements)


Gap analysis of consequences of changed ‘essential requirements’ for recertification of existing devices (rule 21, Annex XV)


ANNEX II TECHNICAL DOCUMENTATION

Gap analysis of existing technical files against new technical file requirements

Amend existing technical files against new technical file requirements and recertification based on amended technical file

Use new technical file requirements

ANNEX III EU DECLARATION OF CONFORMITY

Gap analysis of existing DOC against new DOC requirements

Amend existing DOC against new DOC requirements and recertification based on amended technical file

Use new DOC requirements

ANNEX IV CE MARKING OF CONFORMITY

No changes No changes No changes

ANNEX V INFORMATION TO BE SUBMITTED WITH THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS

Perform gap analysis of information for EUDAMED database and for UDI purposes

Prepare for implementation for EU-UDI

Implement EU-UDI for existing and new devices and register them in EUDAMED database

Use EU-UDI and register new devices in EUDAMED

ANNEX VI MINIMUM REQUIREMENTS TO BE MET BY NOTIFIED BODIES

Contact notified body to discuss if it can meet the new requirements and prepare for transition if needed

Notified body may or may not be re-notified under new criteria; move to new notified body in case notified body not re-notified or has scope restricted as to not support devices concerned any longer

ANNEX VII CLASSIFICATION CRITERIA

Analyse devices under new classification criteria to determine if they will be reclassified

Recertification of existing devices under new classification rules

Apply new classification rules to new devices

ANNEX VIII CONFORMITY ASSESSMENT BASED ON FULL A QUALITY MANAGEMENT SYSTEM ASSURANCE AND DESIGN EXAMINATION

Perform gap analysis between current full QMS and new full QMS requirements, improve QMS where necessary


Apply new QMS

Continued

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ANNEX IX CONFORMITY ASSESSEMENT BASED ON TYPE EXAMINATION

Perform gap analysis between current type examination QMS and new type examination QMS requirements, improve QMS where necessary


Apply new QMS

ANNEX X CONFORMITY ASSESSEMENT BASED ON PRODUCT CONFORMITY VERIFICATION

Perform gap analysis between current product verification QMS and new product verification QMS requirements, improve QMS where necessary


Apply new QMS

ANNEX XI CONFORMITY ASSESSMENT PROCEDURE FOR CUSTOM-MADE DEVICES

Apply procedure for custom-made devices optionally to devices in scope

Apply procedure for custom-made devices in scope

ANNEX XII MINIMUM CONTENT OF CERTIFICATES ISSUED BY A NOTIFIED BODY




ANNEX XIII CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP

Perform gap analysis of current clinical evaluation method and outcomes per devices against new requirements

Implement new requirements for clinical evaluation

Generate clinical evidence to meet new requirements


Generate clinical evidence to new requirements; apply new requirements

Perform gap analysis of current PMCF method and outcomes per device against new requirements

Implement new requirements for PMCF, generate clinical evidence to meet new requirements


Generate PMCF to new requirements; apply new requirements

ANNEX XIV CLINICAL INVESTIGATIONS

Perform gap analysis to determine new clinical investigation requirements and impact on existing clinical investigation plans



ANNEX XV LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE

Identify Annex XV candidate devices in company’s portfolio

Watch for CS becoming available for devices concerned

Start building up technical documentation and if necessary quality management system (QMS)

CE mark Annex XV devices using CS

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BSI is grateful for the help of the following people in the development of the white paper series.

AuthorsDr Gert W. Bos, Executive Director and Partner at Qserve consultancy

Gert has 21 years of experience in life sciences (devices and pharma), in university, industry as well as in four notified bodies. His last notified body roles were Head of Regulatory and Clinical Affairs of BSI Medtech and Head of Notified Body at BSI-Germany (NB0535). He has been President of the Notified Body association TEAM-NB, and Vice Chair of the Medical Notified Body forum NB-Med in Brussels. In these roles for many years, he represented notified bodies in a.o. the Clinical Investigation and Evaluation Group (CIE), Medical Device Expert Group (MDEG) and the MDEG workgroups on animal tissue, on MRAs, e-labeling, EUDAMED and on IVDs, as well as the IMDRF workgroup on Regulated Product Submissions and Table of Content. In addition, he served as NB-representative at EMA/CAT and Medical Device Collaboration group. He is a founding board member of the Dutch RAPS chapter.

Erik Vollebregt, Partner, Axon Lawyers

Erik is a lawyer specializing in EU legal issues relating to medical devices. He has wide experience in life sciences legislation and regulatory issues, at both the EU and Dutch level. Vollebregt was trained as an intellectual property and competition lawyer. He has gained experience in contentious matters, commercial contracts, and transactional work at the Directorate-General for Competition of the European Commission. He is a prolific writer and publishes in life sciences legal and regulatory journals on a wide variety of subjects. Vollebregt authored several medical technology chapters of RAPS Fundamentals of EU Regulatory Affairs and is writing a chapter on software for Fundamentals of International Regulatory Affairs.

Expert ReviewersLeo Eisner, Principal Consultant of Eisner Safety Consultants

Leo’s firm specializes in helping clients through product safety, international regulatory and quality system processes. Leo is a Notified Body Auditor for NEMKO (previously for NSAI & TÜV PS). Leo is the convener of IEC SC62D JWG9 (IEC/ISO 80601-2-58) and a committee member of US TAG for TC62, SC62A and SC62D. Leo is a registered professional engineer in safety and has 28 years’ experience in product safety. Leo is a member of RAPS, AAMI, ASQ, & IEEE. He’s manager of the LinkedIn discussion group IEC 60601 Series – Medical Electrical Equipment.

Sabina Hoekstra-van den Bosch, Lead for European Regulation, Global Standards and Regulations, Philips Healthcare

Sabina joined Philips Healthcare in 2011 after an extensive career as pharmaceutical and medical device regulator in the Dutch Government, in which she has represented the Netherlands in several EU and international working groups. In her present role, she is also acting as Vice-Chair EU Regulatory Affairs Focus Groups of COCIR (European trade association for the Radiological, Electromedical and Healthcare IT Industry), Chair of Netherlands Chapter of RAPS (Regulatory Affairs Professional Society) and Member of the Content Committee for Europe and Faculty Chair for medical devices of DIA (Drug Information Association).

Advisory Panel

Jane Edwards, Global Product Manager, BSI

Jane holds a BSc in Chemistry and an MBA from Durham university. She has over 10 years’ experience in the medical device industry, having previously worked for Coloplast in their ostomy and continence business. Jane’s experience includes working within the pharmaceutical, chemical and telecoms industries for Glaxo Wellcome, ICI and Ericsson, allowing her to bring depth of knowledge from across many industries and technologies. Her current role in BSI allows her to work with technical reviewers across all disciplines ensuring that all BSI communications are accurate and relevant. She is a member of the European Medical Writers Association.

Terry Longman, Standards Consultant

Terry has been employed in the medical equipment industry all his working life. Having qualified as a mechanical engineer he then, over the following 40+ years, experienced both sides of the medical industry, the technical side and the commercial side, with various companies that manufactured everything from capital medical equipment to consumable medical devices.

Since 1995, he has been a self-employed consultant specializing in all matters related to standards including advising companies on compliance with the European Medical Devices Directive and US FDA directives. He represents the members of the British Anaesthetic and Respiratory Manufacturers Association (BAREMA) at BSI meetings. BAREMA comprises manufacturers from all parts of the Anaesthetic and Respiratory industry. He also represents several individual companies at ISO and CEN meetings. Terry is on several national, European and international standards committees, the following as Chairman: CEN/TC/215, CH/121, CH/121/1, CH/121/5, CH/121/9 and CH/210/5.

Pete Philips, Director of the Surgical Materials Testing Laboratory (SMTL)

SMTL, based in Bridgend in South Wales, is funded by the Welsh Government to test medical devices for the Welsh NHS and to provide technical advice on medical devices. Pete has worked in the medical devices field for 30+ years, and sits on a number of BSI, CEN and ISO medical device committees and groups. He chairs the Welsh NonLuer Connectors Reference Group (WNCRG) for Welsh Government, which is coordinating the implementation of new ISO-compliant non-Luer connectors across the Welsh NHS, and represents Welsh Government on medical devices on various other groups.

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Published white papersThe Proposed EU Regulations for Medical and In Vitro Diagnostic Devices: An Overview of the Likely Outcomes and Consequences for the Market, Gert Bos and Erik Vollebregt

Generating Clinical Evaluation Reports – A Guide to Effectively Analysing Medical Device Safety and Performance, Hassan Achakri, Peter Fennema and Itoro Udofia

Effective Post-market Surveillance – Understanding and Conducting Vigilance and Post-market Clinical Follow-up, Ibim Tariah and Rebecca Pine

What You Need to Know About the FDA’s UDI System Final Rule, Jay Crowley and Amy Fowler

Engaging Stakeholders in the Home Medical Device Market: Delivering Personalized and Integrated Care, Kristin Bayer, Laura Mitchell, Sharmila Gardner and Rebecca Pine

Negotiating the Innovation and Regulatory Conundrum, Mike Schmidt and Jon Sherman

The Growing Role of Human Factors and Usability Engineering for Medical Devices: What’s Required in the New Regulatory Landscape? Bob North

ISO 13485: The Proposed Changes and What They Mean for You, Bill Enos and Mark Swanson

Forthcoming white papersThe Differences and Similarities between ISO 9001 and ISO 13485, Mark Swanson

How to Prepare for and Implement the Upcoming IVDR: Dos and Don’ts, Gert Bos and Erik Vollebregt

Sterilization Practices in Response to Device Innovation (working title)

Getting your Clinical Data: Away from Clinical Equivalence in Europe (working title)

The Future of Standards in Europe – Harmonization and other Recognitions of Standards (working title)

Cyber Security for Medical Devices (working title)

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About BSI GroupBSI (British Standards Institution) is the business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. Formed in 1901, BSI was the world’s first National Standards Body and a founding member of the International Organization for Standardization (ISO). Over a century later it continues to facilitate business improvement across the globe by helping its clients drive performance, manage risk and grow sustainably through the adoption of international management systems standards, many of which BSI originated. Renowned for its marks of excellence including the consumer recognized BSI Kitemark™, BSI’s influence spans multiple sectors including aerospace, construction, energy, engineering, finance, healthcare, IT and retail. With over 70,000 clients in 150 countries, BSI is an organization whose standards inspire excellence across the globe.

BSI is keen to hear your views on this paper, or for further information please contact us here: [email protected]

Disclaimer – This white paper is issued for information only. It does not constitute an official or agreed position of BSI Standards Ltd. The views expressed are entirely those of the authors. All rights reserved. Except as permitted under the Copyright, Designs and Patents Act 1988, no part of this publication may be reproduced without prior permission in writing from the publisher. Whilst every care has been taken in developing and compiling this publication, BSI accepts no liability for any loss or damage caused, arising directly or indirectly in connection with reliance on its contents except to the extent that such liability may not be excluded in law. Whilst every effort has been made to trace all copyright holders, anyone claiming copyright should get in touch with the BSI at any of the addresses below.

This paper was published by BSI Standards Ltd

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